PINNACLE R/O OR REDIFOCUS INTRODUCER R/O (COMPRISED OF A SHEATH & DILATOR)
FDA 510(k) clearance K984260 · decided 1999-01-26
Clearance details
- K-number
- K984260
- Device name
- PINNACLE R/O OR REDIFOCUS INTRODUCER R/O (COMPRISED OF A SHEATH & DILATOR)
- Applicant
- Terumo Medical Corp.
- Decision
- Substantially Equivalent
- Date received
- 1998-11-25
- Decision date
- 1999-01-26
- Days to decision
- 62 days
- Clearance type
- Special
- Product code
- DYB
- Device class
- 2
- Regulation number
- 870.1340
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Elkton, MD, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.